Kempf Emmanuelle, Bogaerts Jan, Lacombe Denis, Liu Lifang
The European Organisation for Research and Treatment of Cancer (EORTC), Avenue E. Mounier 83, 1200 Brussels, Belgium.
The European Organisation for Research and Treatment of Cancer (EORTC), Avenue E. Mounier 83, 1200 Brussels, Belgium.
Eur J Cancer. 2017 Nov;86:143-149. doi: 10.1016/j.ejca.2017.08.028. Epub 2017 Oct 4.
In Europe, most of the cancer clinical research dedicated to therapeutic innovations aims primarily at regulatory approval. Once an anticancer drug enters the common market, each member state determines its real-world use based on its own criteria: pricing, reimbursement and clinical indications. Such an innovation-centred clinical research landscape might neglect patient-relevant issues in real-world setting, such as comparative effectiveness of distinct treatment options or long-term safety monitoring. The European Organisation for Research and Treatment of Cancer (EORTC) advocates reforming the current 'innovation-centred' system to a truly 'patient-centred' paradigm with systematically coordinated applied clinical research in conjunction with drug development, featuring the following strategy.
在欧洲,大多数致力于治疗创新的癌症临床研究主要目标是获得监管批准。一旦一种抗癌药物进入普通市场,每个成员国都会根据自身标准确定其实际应用情况:定价、报销和临床适应症。这种以创新为中心的临床研究格局可能会忽视现实环境中与患者相关的问题,比如不同治疗方案的比较疗效或长期安全性监测。欧洲癌症研究与治疗组织(EORTC)主张将当前“以创新为中心”的体系改革为真正“以患者为中心”的模式,在药物研发的同时进行系统协调的应用临床研究,具体策略如下。